TLDR
- Replimune rockets 120% as FDA accepts RP1 resubmission for advanced melanoma.
- RP1 gets FDA nod, sending Replimune stock soaring to near $10 in one session.
- Replimune’s RP1 resubmission gains FDA acceptance, stock hits 4-month high.
- FDA sets 2026 PDUFA date for RP1 Replimune shares explode on news.
- Biotech rally REPL jumps after RP1 BLA resubmission clears FDA hurdle.
Replimune Group(REPL) stock surged 120.66% to $9.93 after the U.S. Food and Drug Administration accepted the resubmission of its Biologics License Application for RP1.
The strong rally followed the company’s announcement of the FDA’s decision to set a new PDUFA date of April 10, 2026. The sharp market reaction reflected renewed optimism surrounding the progress of Replimune’s lead immunotherapy program.
Replimune Group, Inc. confirmed that the FDA classified the resubmission of RP1 as a Class II application, restarting the review timeline. The development positioned the company’s RP1 program back on track after addressing feedback from the earlier complete response letter received in July 2025. Replimune regained significant market attention and confidence in its melanoma treatment platform.
The stock’s steep climb underscored strong enthusiasm for RP1’s potential as a novel therapeutic option in advanced melanoma. Replimune Group, Inc. attributed the BLA resubmission to the inclusion of new analyses and additional data requested by the agency. The company emphasized its goal to advance RP1 toward regulatory approval in combination with nivolumab.
RP1 Program Progress and Regulatory Momentum
Replimune Group, Inc. developed RP1, also known as vusolimogene oderparepvec, as an engineered herpes simplex virus therapy. The candidate is genetically armed with GALV-GP R- and GM-CSF to enhance tumor cell destruction and immune response. RP1 aims to generate robust local and systemic anti-tumor activity in patients with advanced disease.
The FDA’s acceptance of the BLA resubmission marked a critical step in Replimune’s clinical and regulatory strategy. It validated the company’s efforts to resolve outstanding issues raised in the earlier review process. This progress could accelerate the potential pathway toward market approval if the FDA review remains favorable.
Replimune Group, Inc. continues to strengthen its position in oncolytic immunotherapy by advancing RP1 across multiple cancer indications. The therapy’s combination with nivolumab represents a strategic approach to enhance efficacy in patients resistant to PD-1 inhibitors. The company’s pipeline focus remains centered on driving durable responses in challenging cancer types.
Market Reaction and Future Outlook
Replimune Group, Inc. stock maintained steady trading around $9.90 after the early surge. The stock’s movement suggested strong momentum and emerging resistance near the $10 mark. The notable price action reflected renewed market confidence in the company’s therapeutic prospects.
Analysts noted that the acceptance of RP1’s BLA resubmission could signal a potential turning point for Replimune Group, Inc. The positive regulatory development positioned the company to regain traction in the biotechnology sector. Continued updates from the FDA review will remain crucial in shaping RP1’s commercial pathway.
Replimune Group, Inc. now aims to work closely with regulators to ensure a timely and efficient review process. The company’s progress on RP1 reinforces its leadership in advancing oncolytic immunotherapies. The recent milestone solidifies its long-term potential within the oncology innovation landscape.
Get 3 Free Stock Ebooks
Discover top-performing stocks in AI, Crypto, and Technology with expert analysis.
- Top 10 AI Stocks - Leading AI companies
- Top 10 Crypto Stocks - Blockchain leaders
- Top 10 Tech Stocks - Tech giants
